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#Covid19: SAHPRA to control access to Ivermectin

───   14:56 Wed, 27 Jan 2021 The South African Health Products Regulatory Authority (SAHPRA) has resolved to facilitate controlled access to Ivermectin for COVID-19 treatment. SAHPRA says it will be engaging with medical professionals and a guideline will be published soon. There has been much debate around the use of the drug. South Africa s COVID-19 death toll is 41,797. Confirmed COVID-19 cases are now over 1.4 million. BREAKING: @SAHPRA1 has resolved to facilitate a controlled access programme of the ivermectin.— @SAgovnews (@SAgovnews) January 27, 2021 .@SAHPRA1 CEO Boitumelo Semete says the will have healthcare practitioners reporting to us on rollout. She says studies are saying “we cannot prove that there is risk or there is significant benefit, we’ve considered that. The framework will be communicated and will be revolving”— @SAgovnews (@SAgovnews) January 27, 2021

Ivermectin gets partial greenlight to fight Covid

Ivermectin gets partial greenlight to fight Covid Decision comes as many doctors call for it, but health products regulatory authority says better data needed to establish safety, doses and efficacy 27 January 2021 - 16:03 CAUTIOUS The SA Health Products Regulatory Authority on Wednesday gave the partial greenlight for the use of Ivermectin to fight Covid-19. Image: Supplied The SA Health Products Regulatory Authority (Sahpra) announced on Wednesday that it had authorised a limited “compassionate and controlled access programme” for Ivermectin to be used to treat Covid-19. To date, the drug is not authorised for human use in SA. Prof Helen Rees, chairperson of Sahpra, said there was not yet sufficient data to indicate a full authorisation of the drug for human use, but that the programme put in place would “give respite while we wait for better data”. And, she said, it would at least ensure the quality of the product was of a high standa

J&J completes enrollment of Covid vaccine trial, and first to apply for vaccine registration in SA

Approximately 45 000 volunteers are partaking in the trial, and results are expected in February 2021 J&J also became the first of the vaccine developers to apply for Covid vaccine registration in SA, SAHPRA confirmed on Monday Pharmaceutical company Johnson & Johnson’s large-scale Phase 3 Covid-19 vaccine clinical trial (ENSEMBLE) of their Janssen single-dose vaccine candidate is now fully enrolled with approximately 45 000 participants, the company announced on Thursday. “Given the high incidence of Covid-19 among the general population in the countries where the trial is being conducted, this number of participants will be sufficient to generate the data needed to determine the efficacy and safety of the Company’s investigational Covid-19 vaccine candidate,” they stated.

Health Department warns against perception that COVID-19 vaccines are harmful - SABC News - Breaking news, special reports, world, business, sport coverage of all South African current events Africa s news leader

Health Department warns against perception that COVID-19 vaccines are harmful - SABC News - Breaking news, special reports, world, business, sport coverage of all South African current events Africa s news leader
sabcnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from sabcnews.com Daily Mail and Mail on Sunday newspapers.

Johnson & Johnson submit South Africa s first vaccination application

December 15, 2020 Vaccination Source: Google Images Johnson & Johnson is the first pharmaceutical company in South Africa to register a COVID-19 vaccination. The news was announced by the South African Health Products Regulatory Authority (Sahpra) on Monday, December 14. Sahpra chief executive, Boitumelo Semete,  , confirming that Johnson & Johnson’s application was received on Thursday, December 10. An official review process has now started, and will be carried out by Sahpra. According to Semete, Sahpra would focus on the quality, safety and efficacy of the vaccine. She added that a number of pre-submission discussions were also carried out between the regulator and various pharmaceutical companies, which advised on the data required for a successful submission.

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